MAUDE Adverse Event Report: EVOLVE DENTAL TECHNOLOGIES KOR TEETH DESENSITIZER; AGENT, TOOTH BONDING, RESIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)

Event Date 05/11/2015

Event Type  Injury  

Event Description

Dentist office emailed evolve on (b)(6) 2015, reporting pt: "had kor bleach trays made and we delivered them on (b)(6) 2015.First few times using the bleach material, pt placed too much in the trays causing the bleach material to leave the normal white- area where the bleach touches.We again saw her on (b)(6) 2015- pt.Gums were swollen and in a lot of pain." contacted the office and informed them of the potential hema allergy and for the pt to stop all whitening until swelling goes down and then to whiten one night to confirm it was the desensitizer and not related to the bleach.On (b)(6), the pt went to her doctor after the symptoms were not subsiding.The doctor prescribed medication and the symptoms quickly subsided.Following up on (b)(6) 2015.Dentist's office concluded that pt had an allergic reaction.After a week and a doctor's visit, the symptoms have subsided.

Manufacturer Narrative

Possible allergic reaction to the hema in the desensitizer.

• Brand Name: KOR TEETH DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES; irvine CA
• Manufacturer Contact: matt carpenter ; 5 vanderbilt; irvine, CA 92618
• MDR Report Key: 4874679
• MDR Text Key: 6259108
• Report Number: 3010407924-2015-00012
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Weight: 64